Universal reference book for medicines
Product name: HALIXOL ® (HALIXOL ® )

Active substance: ambroxol

Type: Mucolytic and expectorant

Manufacturer: EGIS Pharmaceuticals (Hungary)
Composition, form of production and packaging
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The syrup is colorless or pale yellow, clear, without sediment, with a characteristic odor.
10 ml

Ambroxol hydrochloride 30 mg

Excipients: sorbitol, povidone K90, citric acid monohydrate, sodium cyclamate, strawberry flavor 22754, banana flavor 270650, sodium benzoate, sodium citrate, purified water.

100 ml - bottles of dark glass (1) complete with a measuring cup - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Expectorant (mucolytic) drug.
Ambroxol is an active metabolite of bromhexine, belongs to the benzylamine group of mucolytic substances.
It dilutes sputum by increasing the production and increasing activity of hydrolytic enzymes that break down the bonds between mucopolysaccharides of sputum.

Improves the rheological properties of sputum, reducing its viscosity and adhesive properties, by stimulating serous cells of the glands of the bronchial mucosa and normalizing the ratio of mucous and serous sputum components.
Increases mucociliary transport, increasing the motor activity of the ciliated epithelium. Does not cause excessive secretion, reduces spastic hyperreactivity of the bronchi.
Contributes to the production of surfactant.

The effect develops 30 minutes after taking the drug.

PHARMACOKINETICS

Suction

After oral administration, it is almost completely absorbed from the digestive tract.
Bioavailability after oral administration is approximately 60%. Time to reach C maxin blood plasma - 2 h.
Distribution

Binding to plasma proteins is about 80%.

Penetrates through the placental barrier.
Its concentration in the fetus is 2-4 times higher than that of the mother. It is found in breast milk and cerebrospinal fluid.
Metabolism

It is exposed to active metabolism at the "first passage" through the liver.

Excretion

T 1/2 is about 7 hours.

About 90% of the dose taken is excreted in the urine in the form of glucuronide conjugate ambroxol or oxidized products of its metabolism.

Pharmacokinetics in special clinical cases

T 1/2 increases with severe renal failure, it does not change if liver function is impaired.

INDICATIONS

- acute and chronic diseases of the respiratory system, accompanied by the formation of viscous sputum: bronchitis, bronchial asthma, chronic obstructive pulmonary disease, pneumonia, bronchoectatic disease;

- inflammatory diseases of the ENT organs (sinusitis, otitis), which require liquefaction of mucus.

DOSING MODE

Inside after eating, squeezed a lot of liquid.
A syrup can be taken with a measuring cup in the package. Abundant fluid intake contributes to liquefaction of mucus during treatment with Chaliixol.
Adults and children over 12 years of age : the usual daily dose in the first 2-3 days of 10 ml 3 times / day, and in the following days - 10 ml 2 times / day or 5 ml 3 times / day.
In severe cases, the dose is not reduced throughout the course of treatment.
Children aged 5-12 years are prescribed 5 ml 2-3 times / day.

Children aged 2-5 years are prescribed 2.5 ml syrup 3 times a day.

Children under 2 years of age are prescribed 2.5 ml syrup 2 times a day.

In patients with severe renal insufficiency, the drug should be given at low doses or increased intervals between doses.

The doctor decides individually whether to take Chaliixol for more than 4-5 days.

SIDE EFFECT

From the side of the central nervous system: rarely - weakness, headache.

From the digestive system: rarely - diarrhea, constipation, dry mouth, gastralgia, nausea, vomiting.

On the part of the respiratory system: rarely - dry airways, rhinorrhea.

Allergic reactions: rarely - exanthema, urticaria;
extremely rare - acute anaphylactic reactions, the causal relationship of which with the use of ambroxol is not established.
Other: dysuria.

Halixol, as a rule, is well tolerated.

CONTRAINDICATIONS

ulcerative gastrointestinal lesion;

- I trimester of pregnancy;

- lactation period (breastfeeding);

- hypersensitivity to ambroxol or bromhexine;

With caution should be used in patients with severe renal failure.

PREGNANCY AND LACTATION

The drug is contraindicated in the first trimester of pregnancy.

Ambroxol is excreted in breast milk, so if you need to use the drug during lactation, you should decide whether to stop breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should be used in patients with severe renal failure.
In patients with severe renal insufficiency, the drug should be given at low doses or increased intervals between doses

APPLICATION FOR CHILDREN

In children, the drug is used according to the indications.

SPECIAL INSTRUCTIONS

You should not prescribe concomitantly with antitussive drugs due to difficulty in sputum production.

The use of the drug in patients with impaired bronchial motor function or abundant sputum with low viscosity requires caution because of the danger of stagnation of bronchial secretions.

The syrup contains nonspecific sweeteners, sorbitol, sodium cyclamate, so patients with diabetes can use this drug, but the content of sorbitol (1.2 g per 5 ml) should be taken into account by patients suffering from diabetes mellitus.

The drug does not contain alcohol.

OVERDOSE

Symptoms: nausea, vomiting, diarrhea, indigestion.

Treatment: induce vomiting, then prescribe a drink (milk or tea), intake of fat-containing foods.
Gastric lavage is recommended for 1 -2 hours after taking the drug. It is necessary to constantly monitor the function of the cardiovascular system.
DRUG INTERACTION

Antitussive medications (including codeine) can make it difficult to secrete sputum, liquefied with ambroxol.

Halixol ® promotes penetration of some antibiotics into the bronchial secret (including amoxicillin, cefuroxime, erythromycin, doxycycline).

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored at a temperature of 15 ° to 25 ° C out of the reach of children.
Shelf life - 5 years.
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